The German Parliament (Bundestag) is looking into the government’s proposal issued in early November to tackle increasing supply bottlenecks for pharmaceuticals. On December 12, 2019, the German Parliament held its first reading on the written proposal, which provides chiefly for the following legislative amendments:
- Alleviation of labeling and package leaflet language requirements
In the event of an imminent or existing supply bottleneck of medicinal products, the marketing authorization holder may request the competent federal authority (BfArM or PEI) to allow the medicinal product to be placed on the market with non-German labelling and package leaflet. However, this exception only applies to medicinal products intended for human use and directly administered to patients by doctors or dentists, and which may only be granted in individual cases for a limited period.
- Storage obligation
Marketing authorization holders, wholesalers and distributors can be obligated by BfArM or PEI to take appropriate measures in the event of an imminent or existing supply bottleneck. Depending on the individual case and the impact of the bottleneck for the supply, the higher federal authority can issue, for instance, orders for minimum storage quotas.
- Obligation to inform
Wholesalers of pharmaceutical products shall be obligated, upon request of the competent federal authority, to transmit data on the available stocks and the sales volume of their pharmaceutical products in the event of an imminent or existing supply bottleneck.
- Derogation from the rebate agreement between the pharmaceutical sector and health insurers (Rabattvertrag)
Generally, pharmacists are required to substitute the prescribed medicine with cheaper medicinal products that fall under (tendered) rebate agreements. However, suppliers of rebated medicines have experienced supply shortages in the past. In order to address supply shortages of rebated medicines, the government’s proposal provides that pharmacies may dispense a different drug containing the same active substance if the rebated medicine is not available within 24 hours. The alternative drug dispensed does not need to be rebated but may not be more expensive than the originally prescribed drug.
The aforementioned suggestions are being implemented via an omnibus law. For this purpose, the government chose as legislative vehicle the Fair Health Insurance Carrier Competition Act (GKV-FKG), which primarily regulates the risk and organizational aspects of statutory health insurance carriers (GKV). The completion of the legislative process may be expected in March 2020. The exact wording of the legislation remains under discussion, which applies in particular to the proposed derogation from the rebate agreement.